FDA Inspection
KVK Tech, Inc.KVK Tech, Inc. – FDA Inspection, Aug 4, 2026
Record Details
This FDA Inspection record concerns KVK Tech, Inc., with an inspection on August 4, 2026, issued by the Philadelphia District Office, covering human drugs.
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ID · ad6f2669-0486-4265-98ad-54fa69c278e3
Inspection Facts
- Inspection number
- 1329488
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.188(b)(6)Documentation of Packaging and Labeling Area Inspections
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of KVK Tech, Inc.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2025 | OAI | Philadelphia District Office | Drug Quality Assurance |
| October 21, 2024 | Not classified | Philadelphia District Office | |
| July 8, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 16, 2019 | OAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| September 21, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for KVK Tech, Inc.
- FDA Inspection 1233334 - 2025-03-14
- FDA Inspection 1229759 - 2024-10-21
- FDA Inspection 1175552 - 2022-07-08
- FDA Inspection 1086467 - 2019-04-16
- FDA Inspection 1066940 - 2018-09-21
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